title: Oral risedronate sodium improves bone mineral density in non-ambulatory patients: a randomized, double-blind, placebo controlled trial.
abstract: OBJECTIVE
  Investigate the efficacy of risedronate sodium (Procter and Gamble, Cincinnati, USA) for treating reduced lumbar spine (LS) bone mineral density (BMD) in non-ambulatory patients.
  
  
  METHODS
  Nine (10-39 years, mean age 23.0 years, 7 males) in the risedronate arm and 10 (10-35 years, mean age 21.4 years, 8 males) in the placebo arm completed 24 months of therapy at baseline, 6, 12, 18, and 24 months. The primary outcome was change in LS BMD assessed by dual energy x-ray absorptiometry (DXA). Secondary outcomes included changes in serum bone markers, bone specific alkaline phosphatase, osteocalcin, and N-telopeptides. Mixed models examined group, time, and the group by time interaction for the 4 post-baseline time points.
  
  
  RESULTS
  The change in LS BMD score from baseline to 24 months was 0.069 (95% CI 0.014 to 0.124) in risedronate participants compared to -0.015 (95% CI -0.073 to 0.042) (t Value = -2.40, P > t=0.03) in the controls. When controlling for baseline scores, the difference was consistent across four post-baseline time points tested (F=5.67, Pr > F=0.03). No differences in serum bone markers were observed.
  
  
  CONCLUSIONS
  Risedronate increases LS BMD in non-ambulatory patients with minimal side effects.
authors.affiliation: Division of Pediatric Gastroenterology, Hepatology, and Nutrition, The Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
authors.forename: Valeria
authors.initials: V
authors.lastname: Cohran
authors.forename: Amy
authors.initials: A
authors.lastname: Cassedy
authors.forename: Andre
authors.initials: A
authors.lastname: Hawkins
authors.forename: Judy
authors.initials: J
authors.lastname: Bean
authors.forename: James
authors.initials: J
authors.lastname: Heubi
mesh_terms: D015502:Absorptiometry, Photon; D000293:Adolescent; D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D002547:Cerebral Palsy / Q000473:pathology*; D002648:Child; D024042:Collagen Type I / Q000097:blood; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects*; D008297:Male; D015675:Osteocalcin / Q000097:blood; D010455:Peptides / Q000097:blood; D000068296:Risedronic Acid; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; D000469:Alkaline Phosphatase; D000068296:Risedronic Acid; D012968:Etidronic Acid